B
1. Name Of The Medicinal Product
Brolene Eye Drops.
2. Qualitative And Quantitative Composition
Propamidine isetionate 0.1% w/v.
3. Pharmaceutical Form
Eye drops.
4. Clinical Particulars
4.1 Therapeutic Indications
Propamidine isetionate is an aromatic diamidine disinfectant which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.
4.2 Posology And Method Of Administration
One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.
4.3 Contraindications
Hypersensitivity to propamidine or any other component of the preparation.
4.4 Special Warnings And Precautions For Use
If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.
If there is no significant improvement after two days' therapy, discontinue use and consult a physician.
The eye drops are unsuitable for use with hard or soft contact lenses.
The drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, seven days after first opening.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.
4.7 Effects On Ability To Drive And Use Machines
May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.
4.8 Undesirable Effects
Hypersensitivity may occur.
Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.
4.9 Overdose
Topical overdosage not applicable. Oral ingestion of a full 10ml bottle is unlikely to cause any toxic effects.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Propamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of organisms. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli, the activity of the diamidines being retained in the presence of organic matter such as tissue fluids, pus and serum.
5.2 Pharmacokinetic Properties
No data available.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ammonium chloride, Sodium chloride, Benzalkonium chloride, Sodium hydroxide, Water for injections.
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months
Once opened the drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, 7 days after first opening.
6.4 Special Precautions For Storage
Store below 25oC.
6.5 Nature And Contents Of Container
10 ml plastic dropper bottle and tamper-proof cap.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
8. Marketing Authorisation Number(S)
PL 04425/0197
9. Date Of First Authorisation/Renewal Of The Authorisation
07 November 2002
10. Date Of Revision Of The Text
12 April 2010
LEGAL CLASSIFICATION
P
Brolene Eye Drops
.
